I could not find any source for CE mark approval of the new Fitbone nail. Do you have a source? because you said it is used in Germany.
In the US, no well known surgeon uses it for cosmetic. Do a search on the Fitbone surgeon directory.
South Africa is quite risky. I would not trust their medical board even if Dr Birkholtz is good. Getting a brand new nail inserted into both femur bones? better be sure that it has full regulatory approval of developed countries if you asking me
I sent Thaller an email but I guess you are corrent in that there is no EU approval yet only US - similar to the PMax nail.
Yes, you are correct in that using that nail in SA is probably quite risky. However, it does have regulatory approval by the FDA if that means anything. Also, I know of one Birkholtz patient who is 1.5cm into distraction with the new Fitbone and no issues thus far. Given the nail is made of Molybdenum it is unlikely to break - worst case scenario is probably that it stops distracting.
However, the P2.2 has issues with locking bolts.
The question still remains whether the increased weight-bearing during distraction outweighs the potential risks of it being a new decive.